Quality Engineer I

About the Company

HepQuant is a clinical laboratory with headquarters in Denver and a CLIA-accredited lab in Aurora, Colorado. HepQuant develops minimally invasive, blood-based quantitative tests that measure liver health. Our tests deliver information about liver cell function and portal-systemic shunting, attributes of liver disease that are associated with clinical outcomes. Results may be used by a physician in conjunction with clinical evaluation and other tests to aid clinical management.

Hiring Timeline

We are planning ahead for organizational growth and expect to formally hire for this position in
January of 2026
. We are posting early to build a pipeline of strong candidates and begin conversations with those who may be a great fit. If you are interested, we encourage you to apply now; interviews will begin closer to the hire date.

About the Role

HepQuant is seeking a dedicated and motivated individual to be responsible for providing quality assurance and engineering support for clinical and commercial In-Vitro Diagnostics; maintaining, and improving the Quality Management System (QMS) process and methods; and ensuring alignment with all applicable FDA, CLSI, European MDR, IVD-R, and ISO requirements i.e., 21 CFR parts 4; 820; 210; 211, IEC 62304, ISO13485/ 14971/ 13408, etc., while utilizing metrics to continually improve quality processes and efficiency. This position will report to the Director of Quality & Engineering.

Responsibilities

• Ensure adherence to internal standards and compliance with formal external quality standards, such as ISO 14971 & ISO 13485.
• Identify and document potential nonconformities and perform root cause analysis for quality failures to implement corrective actions.
• Collaborates with cross-functional teams to identify and mitigate quality risks.
• Adherence to change management while providing revisions and updates to quality procedures & standardized work instructions.
• Initiate supplier qualification activities and evaluate supplier performance.
• Conduct audits of production processes and ensure compliance with regulatory standards.
• Assist with design development and